Updated EU Guidance on Conduct of Clinical Trials During COVID-19 Pandemic

On 28 April 2020 the European Commission issued updated guidance on how to manage clinical trials during the Covid-19 pandemic which it prepared with the European Medicines Agency and the national Heads of Medicines Agencies.

The updated guidance includes clarifications on the following topics:

Distribution of investigational medicinal products to patients in clinical trials: the guidance seeks to ensure and protect the safety and wellbeing of clinical trial participants and the integrity of the clinical trials. The new recommendation tackles the complicating nature of social distancing measures and possible limitations on trial site resources.

Remote source data verification (SDV): Social distancing measures introduced to slow the spread of the virus have posed problems for the verification of data at the trial site level. The new guidance outlines alternative approaches including remote SDV could facilitate the marketing authorisation process of potentially life-saving medicines. `

Communication to authorities: The updated guidance clarifies the classification and notification of urgent actions required to protect trial participants from immediate hazard or other changes impacting patient safety or data integrity.